The following data is part of a premarket notification filed by Pharmaseal Div., Baxter Healthcare Corp. with the FDA for Phadecode Xa Inhibitor Assay.
| Device ID | K792019 |
| 510k Number | K792019 |
| Device Name: | PHADECODE XA INHIBITOR ASSAY |
| Classification | Antithrombin Iii Quantitation |
| Applicant | PHARMASEAL DIV., BAXTER HEALTHCARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-09 |
| Decision Date | 1979-11-05 |